BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR LINK Y TYPE BLOOD SOLUTION SET

    MDR report key: 2091240 · Received May 4, 2011

    Report

    Report Number
    2091240
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BAXTER
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    BLOOD TUBING BROKE AT POINT WHERE IT GETS THINNER UNDER THE FILTER. THE TUBING WAS CLAMPED AND BEING REMOVED FROM PUMP WHEN IT BROKE AND BLOODY SALINE SPILLED ALL OVER THE EMPLOYEE. IT WAS NOT CUT OR HANDLED ROUGHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR LINK Y TYPE BLOOD SOLUTION SET BLOOD SOLUTION SET BRZ BAXTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR